BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM ROD 500MM

    MDR report key: 3010177 · Received March 19, 2013

    Report

    Report Number
    8030965-2013-00970
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HARDWARE FROM T4 TO PELVIS ON (B)(6) 2012. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED THE TWO RODS BROKE POST-OPERATIVE. THE RODS BROKE BETWEEN L3 AND L4 IN BETWEEN THE SCREWS, IN THE MIDDLE. REPORTEDLY THE PATIENT WAS COMPLAINING OF PAIN. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR A T10 - L5 POSTERIOR LUMBAR REVISION SURGERY. THE SURGEON REMOVED THE BROKEN RODS AND THE PATIENT WAS REVISED WITH NEW RODS. THIS REPORT IS FOR TWO RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113258 6.0MM ROD 500MM NKB SYNTHES GMBH 7514260

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention